Octadecanoic acid, 12-hydroxy-, reaction products with decanoic acid and ethylenediamine

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study planned

Study period:

2 years from ECHA's approval (final decision on TP)

Justification for type of information:

CONSIDERATIONS OF ALTERNATIVE METHODS ON TESTING PROPOSALS IN YOUR REGISTRATION

Public substance name: Reaction mass of 12-Hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]octadecanamide and N,N'-1,2-Ethanediylbis(12-hydroxyoctadecanamide) and N,N'-1,2-Ethanediylbis[decanamide]

EC Number (omit if confidential): 907-495-0

CAS Number (omit if confidential): 198028-14-7

Date of considerations: 08 December 2021.

• Hazard endpoint for which vertebrate testing was proposed:
Fish early-life stage toxicity study with Reaction mass of 12-Hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]octadecanamide and N,N'-1,2-Ethanediylbis(12-hydroxyoctadecanamide) and N,N'-1,2-Ethanediylbis[decanamide] (EC Number 907-495-0, CAS Number 198028-14-7) according to the OECD Test Guideline 210.


• Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were not adequate to generate the necessary information (instruction: please address all points below):

• available GLP studies
None

• available non-GLP studies
None

• historical human data
Not relevant

• (Q)SAR
To our knowledge, there is no appropriate QSAR for estimating chronic toxicity with same endpoints as the OECD TG 210.

• in vitro methods
To our knowledge, there is no validated in vitro test method for estimating chronic toxicity with same endpoints as the OECD TG 210.

• weight of evidence
There are not enough available data for a weight of evidence approach.

• grouping and read-across
There are no identified groups of substances or similar substances for a read across approach.

• substance-tailored exposure driven testing [if applicable]

• [approaches in addition to above [if applicable]

• other reasons [if applicable]

• Considerations that the specific adaptation possibilities of Annexes VI to X (and column 2 thereof) were not applicable (instruction: free text):

No long-term toxicity to fish study is available for the registered substance.

In accordance with the Decision of the Board of Appeal in case A-011-2018, the REACh Annex IX, Section 9.1., Column 2 does not allow omitting the need to submit information on long-term toxicity to fish under Column 1. Therefore, fish long-term toxicity testing is a standard information requirement under annex IX of REACh regulation EC 1907/2006. Therefore, an OECD 210 study is proposed and cannot be waived.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Test material

Test material information

Constituent 1

Reference substance name:

12-hydroxy-N-[2-(12-hydroxyoctadecanamido)ethyl]octadecanamide; N-(2-decanamidoethyl)-12-hydroxyoctadecanamide; N-(2-decanamidoethyl)decanamide

EC Number:

907-495-0

Cas Number:

198028-14-7

IUPAC Name:

12-hydroxy-N-[2-(12-hydroxyoctadecanamido)ethyl]octadecanamide; N-(2-decanamidoethyl)-12-hydroxyoctadecanamide; N-(2-decanamidoethyl)decanamide

Test material form:

solid

Details on test material:

Chemical name : Reaction mass of N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide) and Octadecanamide, 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]- and Decanamide, N,N'-1,2-ethanediylbis-

Chemical registery number : EC 907-495-0 / CAS : 198028-14-7